immune thrombocytopenia
Conditions
Interventions
CON-group:Bortezomib combined with rituximab
NC-group: rituximab
Sponsors
Fujian Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis met the criteria of childhood primary immune thrombocytopenia 2021; 2. Aged 1-18 years (not including 18); 3. The physical strength score is 1-3 (WHO standard); 4. Morphology of bone marrow cells: >= 50 megakaryocytes ; 5. Children with newly diagnosed ITP must have received standard first-line therapy and at least 2 second-line therapies (note: the second-line drugs must include thrombopoietin receptor agonists); 6. Platelet count = 6 months were dependent on drug therapy (i.e., platelets < 30x10^9/L or bleeding within 4 weeks of drug withdrawal); 7. Family members agree and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Except serious dysfunction of heart, liver, kidney and other important organs; 2. Ccomplicated with other malignant tumors and autoimmune diseases; 3. Children with contraindications for rituximab or bortezomib; 4. Patients who are deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count;Bleeding symptoms;Durable complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total durable response;Total response;Long term complete response;Duration of response;safety; | — |
Countries
China
Contacts
Public ContactHuang Sihan
Fujian Children's Hospital
Outcome results
None listed